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Palliative care update highlights role of nonspecialists
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
Links between SCT and adverse outcomes
Although sickle cell trait (SCT) has been linked to adverse clinical outcomes in multiple studies, only a handful of associations have strong evidence supporting them, according to a systematic review.
Evidence was strongest for the association between SCT and venous and renal complications.
There was low-strength evidence supporting a link between SCT and exertion-related sudden death and moderate-strength evidence supporting a link between SCT and exertion-related rhabdomyolysis.
Most other associations between SCT and clinical outcomes had either low-strength evidence or insufficient data to support a link.
Rakhi P. Naik, MD, of Johns Hopkins University in Baltimore, Maryland, and her colleagues reported these findings in Annals of Internal Medicine.
The researchers’ systematic review was focused on 41 studies, most of which were population-based cohort or case-control studies.
The team rated the evidence quality of each study and grouped 24 clinical outcomes of interest into six categories: exertion-related injury, mortality, and renal, vascular, pediatric, surgery-, and trauma-related outcomes.
The researchers found low-strength evidence for a link between SCT and hematuria, end-stage renal disease, hypertension, myocardial infarction, retinopathy, diabetic vasculopathy, sudden infant death syndrome, surgery- and trauma-related injury, and overall mortality.
There was moderate-strength evidence for a link between SCT and pediatric height/weight, stroke, and heart failure/cardiomyopathy.
Exertion-related injury/death
The strength of evidence for a link between SCT and exertion-related death was low in this analysis, which included two studies of this outcome.
However, Dr. Naik and her colleagues did note that SCT may be associated with a small absolute risk of exertion-related death in extreme conditions, such as highly strenuous athletic training or the military.
There was moderate-strength evidence supporting the link between SCT and exertional rhabdomyolysis, based on two studies.
However, the researchers said the absolute risk of exertional rhabdomyolysis in SCT is small and probably occurs only in high-intensity settings, with risk modified by other genetic and environmental factors.
“We do concur with the American Society of Hematology statement recommending against routine SCT screening in athletics and supporting the consistent use of universal precautions to mitigate exertion-related risk in all persons, regardless of SCT status,” the researchers wrote.
Venous and renal outcomes
High-strength evidence linked pulmonary embolism, with or without deep-vein thrombosis, to SCT. In contrast, there was moderate-strength evidence showing no increased risk of isolated deep-vein thrombosis in individuals with SCT.
“The cause of this paradoxical observation is unknown but may be an increased risk for clot embolization in SCT,” the researchers wrote.
Renal outcomes were often attributed to SCT, and the researchers said there was high-strength evidence to support SCT as a risk factor for both proteinuria and chronic kidney disease (CKD).
Out of six studies of proteinuria, the one high-quality study showed a 1.86-fold increased risk for baseline albuminuria in African Americans with SCT versus those without. The other studies “showed a consistent direction of increased risk for proteinuria with SCT,” according to the researchers.
Out of four CKD studies, the two high-quality studies showed a 1.57- and 1.89-fold increased risk of CKD in African Americans with SCT.
Support for this review came, in part, from the National Human Genome Research Institute and the National Heart, Lung, and Blood Institute. The authors reported disclosures related to Novartis, Addmedica, and Global Blood Therapeutics, among others.
Although sickle cell trait (SCT) has been linked to adverse clinical outcomes in multiple studies, only a handful of associations have strong evidence supporting them, according to a systematic review.
Evidence was strongest for the association between SCT and venous and renal complications.
There was low-strength evidence supporting a link between SCT and exertion-related sudden death and moderate-strength evidence supporting a link between SCT and exertion-related rhabdomyolysis.
Most other associations between SCT and clinical outcomes had either low-strength evidence or insufficient data to support a link.
Rakhi P. Naik, MD, of Johns Hopkins University in Baltimore, Maryland, and her colleagues reported these findings in Annals of Internal Medicine.
The researchers’ systematic review was focused on 41 studies, most of which were population-based cohort or case-control studies.
The team rated the evidence quality of each study and grouped 24 clinical outcomes of interest into six categories: exertion-related injury, mortality, and renal, vascular, pediatric, surgery-, and trauma-related outcomes.
The researchers found low-strength evidence for a link between SCT and hematuria, end-stage renal disease, hypertension, myocardial infarction, retinopathy, diabetic vasculopathy, sudden infant death syndrome, surgery- and trauma-related injury, and overall mortality.
There was moderate-strength evidence for a link between SCT and pediatric height/weight, stroke, and heart failure/cardiomyopathy.
Exertion-related injury/death
The strength of evidence for a link between SCT and exertion-related death was low in this analysis, which included two studies of this outcome.
However, Dr. Naik and her colleagues did note that SCT may be associated with a small absolute risk of exertion-related death in extreme conditions, such as highly strenuous athletic training or the military.
There was moderate-strength evidence supporting the link between SCT and exertional rhabdomyolysis, based on two studies.
However, the researchers said the absolute risk of exertional rhabdomyolysis in SCT is small and probably occurs only in high-intensity settings, with risk modified by other genetic and environmental factors.
“We do concur with the American Society of Hematology statement recommending against routine SCT screening in athletics and supporting the consistent use of universal precautions to mitigate exertion-related risk in all persons, regardless of SCT status,” the researchers wrote.
Venous and renal outcomes
High-strength evidence linked pulmonary embolism, with or without deep-vein thrombosis, to SCT. In contrast, there was moderate-strength evidence showing no increased risk of isolated deep-vein thrombosis in individuals with SCT.
“The cause of this paradoxical observation is unknown but may be an increased risk for clot embolization in SCT,” the researchers wrote.
Renal outcomes were often attributed to SCT, and the researchers said there was high-strength evidence to support SCT as a risk factor for both proteinuria and chronic kidney disease (CKD).
Out of six studies of proteinuria, the one high-quality study showed a 1.86-fold increased risk for baseline albuminuria in African Americans with SCT versus those without. The other studies “showed a consistent direction of increased risk for proteinuria with SCT,” according to the researchers.
Out of four CKD studies, the two high-quality studies showed a 1.57- and 1.89-fold increased risk of CKD in African Americans with SCT.
Support for this review came, in part, from the National Human Genome Research Institute and the National Heart, Lung, and Blood Institute. The authors reported disclosures related to Novartis, Addmedica, and Global Blood Therapeutics, among others.
Although sickle cell trait (SCT) has been linked to adverse clinical outcomes in multiple studies, only a handful of associations have strong evidence supporting them, according to a systematic review.
Evidence was strongest for the association between SCT and venous and renal complications.
There was low-strength evidence supporting a link between SCT and exertion-related sudden death and moderate-strength evidence supporting a link between SCT and exertion-related rhabdomyolysis.
Most other associations between SCT and clinical outcomes had either low-strength evidence or insufficient data to support a link.
Rakhi P. Naik, MD, of Johns Hopkins University in Baltimore, Maryland, and her colleagues reported these findings in Annals of Internal Medicine.
The researchers’ systematic review was focused on 41 studies, most of which were population-based cohort or case-control studies.
The team rated the evidence quality of each study and grouped 24 clinical outcomes of interest into six categories: exertion-related injury, mortality, and renal, vascular, pediatric, surgery-, and trauma-related outcomes.
The researchers found low-strength evidence for a link between SCT and hematuria, end-stage renal disease, hypertension, myocardial infarction, retinopathy, diabetic vasculopathy, sudden infant death syndrome, surgery- and trauma-related injury, and overall mortality.
There was moderate-strength evidence for a link between SCT and pediatric height/weight, stroke, and heart failure/cardiomyopathy.
Exertion-related injury/death
The strength of evidence for a link between SCT and exertion-related death was low in this analysis, which included two studies of this outcome.
However, Dr. Naik and her colleagues did note that SCT may be associated with a small absolute risk of exertion-related death in extreme conditions, such as highly strenuous athletic training or the military.
There was moderate-strength evidence supporting the link between SCT and exertional rhabdomyolysis, based on two studies.
However, the researchers said the absolute risk of exertional rhabdomyolysis in SCT is small and probably occurs only in high-intensity settings, with risk modified by other genetic and environmental factors.
“We do concur with the American Society of Hematology statement recommending against routine SCT screening in athletics and supporting the consistent use of universal precautions to mitigate exertion-related risk in all persons, regardless of SCT status,” the researchers wrote.
Venous and renal outcomes
High-strength evidence linked pulmonary embolism, with or without deep-vein thrombosis, to SCT. In contrast, there was moderate-strength evidence showing no increased risk of isolated deep-vein thrombosis in individuals with SCT.
“The cause of this paradoxical observation is unknown but may be an increased risk for clot embolization in SCT,” the researchers wrote.
Renal outcomes were often attributed to SCT, and the researchers said there was high-strength evidence to support SCT as a risk factor for both proteinuria and chronic kidney disease (CKD).
Out of six studies of proteinuria, the one high-quality study showed a 1.86-fold increased risk for baseline albuminuria in African Americans with SCT versus those without. The other studies “showed a consistent direction of increased risk for proteinuria with SCT,” according to the researchers.
Out of four CKD studies, the two high-quality studies showed a 1.57- and 1.89-fold increased risk of CKD in African Americans with SCT.
Support for this review came, in part, from the National Human Genome Research Institute and the National Heart, Lung, and Blood Institute. The authors reported disclosures related to Novartis, Addmedica, and Global Blood Therapeutics, among others.
Surgical checklist benefits depend on culture change
BOSTON – The success of surgical safety checklists to reduce postoperative mortality appears to depend not only on implementation but also on the degree to which a hospital embraces a culture of teamwork, Atul Gawande, MD, MPH, FACS, said at the annual clinical congress of the American College of Surgeons.
The session “Checking in on the Checklist – Ten Years of the WHO Surgical Safety Checklist” moderated by Thomas Geoghegan Weiser, MD, FACS, and Alex B. Haynes, MD, FACS,considered the progress of the past decade in implementing the World Health Organization initiative in medical institutions around the world.
Team-based approaches to the checklist accompanied by other institutional support have demonstrated double-digit reductions in mortality, while in contrast, a mandate-only approach resulted in a 0% change, said Dr. Gawande, a general and endocrine surgeon at Brigham and Women’s Hospital and professor in the department of health policy and management at the Harvard T.H. Chan School of Public Health and the Samuel O. Thier Professor of Surgery at Harvard Medical School, all in Boston.
Variables including respect among team members, clinical leadership, and assertiveness on behalf of patient safety appeared to be predictive of postoperative death rates in one recent implementation of the WHO Surgical Safety Checklist, he added.
Dr. Gawande said the 29-item surgical safety checklist has earned support but also skepticism and “some outright opposition” in the nearly 10 years since landmark study published in the New England Journal of Medicine, coauthored by Dr. Haynes, reported that the approach cut mortality by 47% and postoperative complication rates by 36%, on average, in a diverse group of eight hospitals throughout the world.
“It’s a challenge in a fundamental way, to our values,” Dr. Gawande told attendees. “What we have valued in our life as surgeons is our autonomy as clinicians, and here was an approach which required you to work with different values: humility, discipline, teamwork.”
That 47% mortality reduction was achieved in a clinical trial setting with “very carefully selected sites” that were enthusiastic about giving the checklist a try, and toward that end, received weekly support, Dr. Gawande said.
Subsequent implementations of the checklist have had varying success rates, he said.
Implementations that have included a mandate plus regular feedback have yielded mortality reductions upward of 26%he said, while a mandate plus team training reduced mortality by 18% in a Veterans Health Administration hospital setting, according to Dr. Gawande. By contrast, a mandate-alone approach in Ontario yielded a 0% reduction in mortality.
“What we came to realize is a kind of formula that underlies how you create change in organizations generally, where you’re trying to create systems that make it easier for people to get the right kinds of things done,” Dr. Gawande said.
“You have a systems tool that has been carefully crafted around the ‘killer items’ – the failure points that even experts fail at – you have an implementation pathway, and then you bring it into a ready environment where people are capable and they’re motivated,” he explained.
A South Carolina initiative that was voluntary and included light-touch support yielded a 22% reduction in hospitals that completed the adoption program, Dr. Gawande said. Of note, investigators in the Safe Surgery 2015: South Carolina Initiative found that perceptions of safety among operating room personnel were associated with the all-cause 30-day postoperative death rate.
“The team found in South Carolina that the predictor of how much change you get is how effective your implementation was in changing the culture to be more team oriented,” Dr. Gawande said.
“You could recognize it by how much change you saw in what the frontline people reported about how much they are respected, how much clinical leadership was actually involved in the way the team works, and the ultimate test; how assertive could people be in raising issues,” he continued. “Did they feel safe to raise issues, and not get their head bitten off, but in fact, find that what they offered had value.”
Dr. Gawande is the founder and executive director of Ariadne Labs, a center for health systems innovation, and the chairman of Lifebox, a not-for-profit organization.
SOURCE: Gawande AA et al. ACS Clinical Congress 2018, Session PS232.
BOSTON – The success of surgical safety checklists to reduce postoperative mortality appears to depend not only on implementation but also on the degree to which a hospital embraces a culture of teamwork, Atul Gawande, MD, MPH, FACS, said at the annual clinical congress of the American College of Surgeons.
The session “Checking in on the Checklist – Ten Years of the WHO Surgical Safety Checklist” moderated by Thomas Geoghegan Weiser, MD, FACS, and Alex B. Haynes, MD, FACS,considered the progress of the past decade in implementing the World Health Organization initiative in medical institutions around the world.
Team-based approaches to the checklist accompanied by other institutional support have demonstrated double-digit reductions in mortality, while in contrast, a mandate-only approach resulted in a 0% change, said Dr. Gawande, a general and endocrine surgeon at Brigham and Women’s Hospital and professor in the department of health policy and management at the Harvard T.H. Chan School of Public Health and the Samuel O. Thier Professor of Surgery at Harvard Medical School, all in Boston.
Variables including respect among team members, clinical leadership, and assertiveness on behalf of patient safety appeared to be predictive of postoperative death rates in one recent implementation of the WHO Surgical Safety Checklist, he added.
Dr. Gawande said the 29-item surgical safety checklist has earned support but also skepticism and “some outright opposition” in the nearly 10 years since landmark study published in the New England Journal of Medicine, coauthored by Dr. Haynes, reported that the approach cut mortality by 47% and postoperative complication rates by 36%, on average, in a diverse group of eight hospitals throughout the world.
“It’s a challenge in a fundamental way, to our values,” Dr. Gawande told attendees. “What we have valued in our life as surgeons is our autonomy as clinicians, and here was an approach which required you to work with different values: humility, discipline, teamwork.”
That 47% mortality reduction was achieved in a clinical trial setting with “very carefully selected sites” that were enthusiastic about giving the checklist a try, and toward that end, received weekly support, Dr. Gawande said.
Subsequent implementations of the checklist have had varying success rates, he said.
Implementations that have included a mandate plus regular feedback have yielded mortality reductions upward of 26%he said, while a mandate plus team training reduced mortality by 18% in a Veterans Health Administration hospital setting, according to Dr. Gawande. By contrast, a mandate-alone approach in Ontario yielded a 0% reduction in mortality.
“What we came to realize is a kind of formula that underlies how you create change in organizations generally, where you’re trying to create systems that make it easier for people to get the right kinds of things done,” Dr. Gawande said.
“You have a systems tool that has been carefully crafted around the ‘killer items’ – the failure points that even experts fail at – you have an implementation pathway, and then you bring it into a ready environment where people are capable and they’re motivated,” he explained.
A South Carolina initiative that was voluntary and included light-touch support yielded a 22% reduction in hospitals that completed the adoption program, Dr. Gawande said. Of note, investigators in the Safe Surgery 2015: South Carolina Initiative found that perceptions of safety among operating room personnel were associated with the all-cause 30-day postoperative death rate.
“The team found in South Carolina that the predictor of how much change you get is how effective your implementation was in changing the culture to be more team oriented,” Dr. Gawande said.
“You could recognize it by how much change you saw in what the frontline people reported about how much they are respected, how much clinical leadership was actually involved in the way the team works, and the ultimate test; how assertive could people be in raising issues,” he continued. “Did they feel safe to raise issues, and not get their head bitten off, but in fact, find that what they offered had value.”
Dr. Gawande is the founder and executive director of Ariadne Labs, a center for health systems innovation, and the chairman of Lifebox, a not-for-profit organization.
SOURCE: Gawande AA et al. ACS Clinical Congress 2018, Session PS232.
BOSTON – The success of surgical safety checklists to reduce postoperative mortality appears to depend not only on implementation but also on the degree to which a hospital embraces a culture of teamwork, Atul Gawande, MD, MPH, FACS, said at the annual clinical congress of the American College of Surgeons.
The session “Checking in on the Checklist – Ten Years of the WHO Surgical Safety Checklist” moderated by Thomas Geoghegan Weiser, MD, FACS, and Alex B. Haynes, MD, FACS,considered the progress of the past decade in implementing the World Health Organization initiative in medical institutions around the world.
Team-based approaches to the checklist accompanied by other institutional support have demonstrated double-digit reductions in mortality, while in contrast, a mandate-only approach resulted in a 0% change, said Dr. Gawande, a general and endocrine surgeon at Brigham and Women’s Hospital and professor in the department of health policy and management at the Harvard T.H. Chan School of Public Health and the Samuel O. Thier Professor of Surgery at Harvard Medical School, all in Boston.
Variables including respect among team members, clinical leadership, and assertiveness on behalf of patient safety appeared to be predictive of postoperative death rates in one recent implementation of the WHO Surgical Safety Checklist, he added.
Dr. Gawande said the 29-item surgical safety checklist has earned support but also skepticism and “some outright opposition” in the nearly 10 years since landmark study published in the New England Journal of Medicine, coauthored by Dr. Haynes, reported that the approach cut mortality by 47% and postoperative complication rates by 36%, on average, in a diverse group of eight hospitals throughout the world.
“It’s a challenge in a fundamental way, to our values,” Dr. Gawande told attendees. “What we have valued in our life as surgeons is our autonomy as clinicians, and here was an approach which required you to work with different values: humility, discipline, teamwork.”
That 47% mortality reduction was achieved in a clinical trial setting with “very carefully selected sites” that were enthusiastic about giving the checklist a try, and toward that end, received weekly support, Dr. Gawande said.
Subsequent implementations of the checklist have had varying success rates, he said.
Implementations that have included a mandate plus regular feedback have yielded mortality reductions upward of 26%he said, while a mandate plus team training reduced mortality by 18% in a Veterans Health Administration hospital setting, according to Dr. Gawande. By contrast, a mandate-alone approach in Ontario yielded a 0% reduction in mortality.
“What we came to realize is a kind of formula that underlies how you create change in organizations generally, where you’re trying to create systems that make it easier for people to get the right kinds of things done,” Dr. Gawande said.
“You have a systems tool that has been carefully crafted around the ‘killer items’ – the failure points that even experts fail at – you have an implementation pathway, and then you bring it into a ready environment where people are capable and they’re motivated,” he explained.
A South Carolina initiative that was voluntary and included light-touch support yielded a 22% reduction in hospitals that completed the adoption program, Dr. Gawande said. Of note, investigators in the Safe Surgery 2015: South Carolina Initiative found that perceptions of safety among operating room personnel were associated with the all-cause 30-day postoperative death rate.
“The team found in South Carolina that the predictor of how much change you get is how effective your implementation was in changing the culture to be more team oriented,” Dr. Gawande said.
“You could recognize it by how much change you saw in what the frontline people reported about how much they are respected, how much clinical leadership was actually involved in the way the team works, and the ultimate test; how assertive could people be in raising issues,” he continued. “Did they feel safe to raise issues, and not get their head bitten off, but in fact, find that what they offered had value.”
Dr. Gawande is the founder and executive director of Ariadne Labs, a center for health systems innovation, and the chairman of Lifebox, a not-for-profit organization.
SOURCE: Gawande AA et al. ACS Clinical Congress 2018, Session PS232.
REPORTING FROM THE ACS CLINICAL CONGRESS
Few clinical outcomes convincingly linked to sickle cell trait
Although sickle cell trait (SCT) has been linked to numerous adverse clinical outcomes in multiple studies, only a handful of those associations have strong supporting evidence, results of a systematic review suggest.
Venous and renal complications had the strongest evidence supporting an association with SCT, while exertion-related sudden death – perhaps the highest-profile potential complication of SCT – had moderate-strength evidence supporting a link, according to the review.
By contrast, most other associations between SCT and clinical outcomes had either low-strength evidence or insufficient data to support a link, according to Rakhi P. Naik, MD, of Johns Hopkins University, Baltimore, and coauthors of the review.
“Future rigorous studies are needed to address potential complications of SCT and to determine modifiers of risk,” they wrote. The report in the Annals of Internal Medicine.
The systematic review by Dr. Naik and colleagues focused on 41 studies, most of which were population-based cohort or case-control studies. They rated the evidence quality of each study and grouped 24 clinical outcomes of interest into six categories: exertion-related injury, renal, vascular, pediatric, surgery- and trauma-related outcomes, and mortality.
Exercise-related injury has received considerable attention, particularly in relation to the military and athletics.
The strength of evidence for a link between SCT and exertion-related death was low in their analysis, which included two studies evaluating the outcome. However, Dr. Naik and coauthors did note that SCT may be associated with a small absolute risk of exertion-related death in extreme conditions such a highly strenuous athletic training or the military.
“We do concur with the American Society of Hematology statement recommending against routine SCT screening in athletics and supporting the consistent use of universal precautions to mitigate exertion-related risk in all persons, regardless of SCT status,” they wrote.
Similarly, the absolute risk of exertional rhabdomyolysis in SCT is small and probably occurs only in high-intensity settings, with risk modified by other genetic and environmental factors, Dr. Naik and coauthors said, based on their analysis of two studies looking at this outcome.
Venous complications had a stronger body of evidence, including several studies showing high levels of procoagulants, which makes elevated venous thromboembolism risk plausible in individuals with SCT.
High-strength evidence linked pulmonary embolism, with or without deep-vein thrombosis, to SCT. In contrast, there was no increased risk of isolated deep-vein thrombosis in these individuals.
“The cause of this paradoxical observation is unknown but may be an increased risk for clot embolization in SCT,” Dr. Naik and colleagues wrote in a discussion of the results.
Renal outcomes were often attributed to SCT, and in this review, the authors said there was evidence to support SCT as a risk factor for both proteinuria and chronic kidney disease.
Out of six studies looking at proteinuria, the one high-quality study found a 1.86-fold increased risk for baseline albuminuria in African Americans with SCT versus those without, according to the review.
Out of four studies looking at chronic kidney disease, the two high-quality studies found 1.57- to 1.89-fold increased risk of those outcomes in African Americans with SCT.
Support for the study came in part from the National Human Genome Research Institute and the National Heart, Lung, and Blood Institute. The authors reported disclosures related to Novartis, Addmedica, and Global Blood Therapeutics, among others.
SOURCE: Naik RP et al. Ann Intern Med. 2018 Oct 30. doi:10.7326/M18-1161.
Although sickle cell trait (SCT) has been linked to numerous adverse clinical outcomes in multiple studies, only a handful of those associations have strong supporting evidence, results of a systematic review suggest.
Venous and renal complications had the strongest evidence supporting an association with SCT, while exertion-related sudden death – perhaps the highest-profile potential complication of SCT – had moderate-strength evidence supporting a link, according to the review.
By contrast, most other associations between SCT and clinical outcomes had either low-strength evidence or insufficient data to support a link, according to Rakhi P. Naik, MD, of Johns Hopkins University, Baltimore, and coauthors of the review.
“Future rigorous studies are needed to address potential complications of SCT and to determine modifiers of risk,” they wrote. The report in the Annals of Internal Medicine.
The systematic review by Dr. Naik and colleagues focused on 41 studies, most of which were population-based cohort or case-control studies. They rated the evidence quality of each study and grouped 24 clinical outcomes of interest into six categories: exertion-related injury, renal, vascular, pediatric, surgery- and trauma-related outcomes, and mortality.
Exercise-related injury has received considerable attention, particularly in relation to the military and athletics.
The strength of evidence for a link between SCT and exertion-related death was low in their analysis, which included two studies evaluating the outcome. However, Dr. Naik and coauthors did note that SCT may be associated with a small absolute risk of exertion-related death in extreme conditions such a highly strenuous athletic training or the military.
“We do concur with the American Society of Hematology statement recommending against routine SCT screening in athletics and supporting the consistent use of universal precautions to mitigate exertion-related risk in all persons, regardless of SCT status,” they wrote.
Similarly, the absolute risk of exertional rhabdomyolysis in SCT is small and probably occurs only in high-intensity settings, with risk modified by other genetic and environmental factors, Dr. Naik and coauthors said, based on their analysis of two studies looking at this outcome.
Venous complications had a stronger body of evidence, including several studies showing high levels of procoagulants, which makes elevated venous thromboembolism risk plausible in individuals with SCT.
High-strength evidence linked pulmonary embolism, with or without deep-vein thrombosis, to SCT. In contrast, there was no increased risk of isolated deep-vein thrombosis in these individuals.
“The cause of this paradoxical observation is unknown but may be an increased risk for clot embolization in SCT,” Dr. Naik and colleagues wrote in a discussion of the results.
Renal outcomes were often attributed to SCT, and in this review, the authors said there was evidence to support SCT as a risk factor for both proteinuria and chronic kidney disease.
Out of six studies looking at proteinuria, the one high-quality study found a 1.86-fold increased risk for baseline albuminuria in African Americans with SCT versus those without, according to the review.
Out of four studies looking at chronic kidney disease, the two high-quality studies found 1.57- to 1.89-fold increased risk of those outcomes in African Americans with SCT.
Support for the study came in part from the National Human Genome Research Institute and the National Heart, Lung, and Blood Institute. The authors reported disclosures related to Novartis, Addmedica, and Global Blood Therapeutics, among others.
SOURCE: Naik RP et al. Ann Intern Med. 2018 Oct 30. doi:10.7326/M18-1161.
Although sickle cell trait (SCT) has been linked to numerous adverse clinical outcomes in multiple studies, only a handful of those associations have strong supporting evidence, results of a systematic review suggest.
Venous and renal complications had the strongest evidence supporting an association with SCT, while exertion-related sudden death – perhaps the highest-profile potential complication of SCT – had moderate-strength evidence supporting a link, according to the review.
By contrast, most other associations between SCT and clinical outcomes had either low-strength evidence or insufficient data to support a link, according to Rakhi P. Naik, MD, of Johns Hopkins University, Baltimore, and coauthors of the review.
“Future rigorous studies are needed to address potential complications of SCT and to determine modifiers of risk,” they wrote. The report in the Annals of Internal Medicine.
The systematic review by Dr. Naik and colleagues focused on 41 studies, most of which were population-based cohort or case-control studies. They rated the evidence quality of each study and grouped 24 clinical outcomes of interest into six categories: exertion-related injury, renal, vascular, pediatric, surgery- and trauma-related outcomes, and mortality.
Exercise-related injury has received considerable attention, particularly in relation to the military and athletics.
The strength of evidence for a link between SCT and exertion-related death was low in their analysis, which included two studies evaluating the outcome. However, Dr. Naik and coauthors did note that SCT may be associated with a small absolute risk of exertion-related death in extreme conditions such a highly strenuous athletic training or the military.
“We do concur with the American Society of Hematology statement recommending against routine SCT screening in athletics and supporting the consistent use of universal precautions to mitigate exertion-related risk in all persons, regardless of SCT status,” they wrote.
Similarly, the absolute risk of exertional rhabdomyolysis in SCT is small and probably occurs only in high-intensity settings, with risk modified by other genetic and environmental factors, Dr. Naik and coauthors said, based on their analysis of two studies looking at this outcome.
Venous complications had a stronger body of evidence, including several studies showing high levels of procoagulants, which makes elevated venous thromboembolism risk plausible in individuals with SCT.
High-strength evidence linked pulmonary embolism, with or without deep-vein thrombosis, to SCT. In contrast, there was no increased risk of isolated deep-vein thrombosis in these individuals.
“The cause of this paradoxical observation is unknown but may be an increased risk for clot embolization in SCT,” Dr. Naik and colleagues wrote in a discussion of the results.
Renal outcomes were often attributed to SCT, and in this review, the authors said there was evidence to support SCT as a risk factor for both proteinuria and chronic kidney disease.
Out of six studies looking at proteinuria, the one high-quality study found a 1.86-fold increased risk for baseline albuminuria in African Americans with SCT versus those without, according to the review.
Out of four studies looking at chronic kidney disease, the two high-quality studies found 1.57- to 1.89-fold increased risk of those outcomes in African Americans with SCT.
Support for the study came in part from the National Human Genome Research Institute and the National Heart, Lung, and Blood Institute. The authors reported disclosures related to Novartis, Addmedica, and Global Blood Therapeutics, among others.
SOURCE: Naik RP et al. Ann Intern Med. 2018 Oct 30. doi:10.7326/M18-1161.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point:
Major finding: Risks of 1.57-fold and higher were seen in high-quality studies linking SCT to venous and renal complications, while studies of moderate quality suggested small absolute risks of exertion-related mortality or rhabdomyolysis.
Study details: A systematic review including 41 mostly population-based cohort or case-control studies looking at 24 clinical outcomes of interest.
Disclosures: Support for the study came in part from the National Human Genome Research Institute and the National Heart, Lung, and Blood Institute. The authors reported disclosures related to Novartis, Addmedica, and Global Blood Therapeutics, among others.
Source: Naik RP et al. Ann Intern Med. 2018 Oct 30. doi:10.7326/M18-1161.
Hemithyroidectomy rates rose after guideline update
BOSTON – that position the procedure as equivalent to total thyroidectomy, an analysis of U.S. hospital data shows.
Patients undergoing hemithyroidectomy had fewer complications and shorter length of stay versus patients who received a bilateral procedure, with no corresponding increase in completion thyroidectomy, according to results of the retrospective analysis reported here at the annual clinical congress of the American College of Surgeons.
“We think this suggests that surgeons might be changing their practice at these hospitals, at least in part in response to the guidelines,” investigator Timothy M. Ullmann, MD, endocrine oncology research fellow in the department of surgery at New York Presbyterian Hospital–Weill Cornell Medical Center, New York.
Dr. Ullmann and colleagues queried the American College of Surgeons National Surgical Quality Improvement Program database for the 2014-2016 period to illustrate operative trends before and after release of the 2015 guidelines from the American Thyroid Association guidelines. They looked at a total of 26,562 procedures done before the guidelines were release, and 7,422 done after.
The rate of hemithyroidectomy increased from 15.6% before guidelines to 18.3% afterward (P less than .001), according to Dr. Ullmann. By contrast, the rates of completion thyroidectomy were 7.8% for the pre-guidelines period and 7.4% post-guidelines (P = .19).
The increase was gradual throughout the 2014-2016 period, though it was especially steep after the guideline introduction, according to co-investigator Toni Beninato, MD, of Weill Cornell Medicine.
“While we can’t say that the guidelines directly caused an increase, it’s a pretty good association,” Dr. Beninato said in a press conference. “I think going forward, we would expect this to continue to increase, because the vast majority of patients with thyroid cancer probably fit criteria to have a hemithyroidectomy rather than a total thyroidectomy.”
Patients treated by otolaryngologists were more likely to undergo hemithyroidectomies versus those treated by general surgeons, multivariate analysis of this data set suggested (odds ratio, 1.13, P less than .001). On the other hand, Hispanic patients and those with a higher operative risk classification were less likely to undergo a unilateral procedure.
Complications were less likely in the hemithyroidectomy patients, according to investigators. There were significantly fewer superficial surgical site infections, at 0.2% versus 0.4% for total thyroidectomy, and operative time was 91.6 minutes versus 141.1 minutes.
Hemithyroidectomy patients were less likely to be reintubated after surgery, had a shorter length of stay, and were more likely to be managed on an outpatient basis, they added at the press conference.
Prior ATA guidelines, in place since 2009, called for near-total or total thyroidectomy for cancers that were at least 1 cm in size in patients with no contraindications to the procedure. The 2015 update says the initial surgical procedure could also be a unilateral procedure, or lobectomy, in cancers greater than 1 cm, or smaller than 4 cm with no extrathyroidal extension.
Dr. Ullmann and Dr. Beninato had no relevant financial relationships with commercial interests pertaining to the content of their presentation.
SOURCE: Ullmann TM et al. Abstract SF121 presented at the American College of Surgeons Clinical Congress.
BOSTON – that position the procedure as equivalent to total thyroidectomy, an analysis of U.S. hospital data shows.
Patients undergoing hemithyroidectomy had fewer complications and shorter length of stay versus patients who received a bilateral procedure, with no corresponding increase in completion thyroidectomy, according to results of the retrospective analysis reported here at the annual clinical congress of the American College of Surgeons.
“We think this suggests that surgeons might be changing their practice at these hospitals, at least in part in response to the guidelines,” investigator Timothy M. Ullmann, MD, endocrine oncology research fellow in the department of surgery at New York Presbyterian Hospital–Weill Cornell Medical Center, New York.
Dr. Ullmann and colleagues queried the American College of Surgeons National Surgical Quality Improvement Program database for the 2014-2016 period to illustrate operative trends before and after release of the 2015 guidelines from the American Thyroid Association guidelines. They looked at a total of 26,562 procedures done before the guidelines were release, and 7,422 done after.
The rate of hemithyroidectomy increased from 15.6% before guidelines to 18.3% afterward (P less than .001), according to Dr. Ullmann. By contrast, the rates of completion thyroidectomy were 7.8% for the pre-guidelines period and 7.4% post-guidelines (P = .19).
The increase was gradual throughout the 2014-2016 period, though it was especially steep after the guideline introduction, according to co-investigator Toni Beninato, MD, of Weill Cornell Medicine.
“While we can’t say that the guidelines directly caused an increase, it’s a pretty good association,” Dr. Beninato said in a press conference. “I think going forward, we would expect this to continue to increase, because the vast majority of patients with thyroid cancer probably fit criteria to have a hemithyroidectomy rather than a total thyroidectomy.”
Patients treated by otolaryngologists were more likely to undergo hemithyroidectomies versus those treated by general surgeons, multivariate analysis of this data set suggested (odds ratio, 1.13, P less than .001). On the other hand, Hispanic patients and those with a higher operative risk classification were less likely to undergo a unilateral procedure.
Complications were less likely in the hemithyroidectomy patients, according to investigators. There were significantly fewer superficial surgical site infections, at 0.2% versus 0.4% for total thyroidectomy, and operative time was 91.6 minutes versus 141.1 minutes.
Hemithyroidectomy patients were less likely to be reintubated after surgery, had a shorter length of stay, and were more likely to be managed on an outpatient basis, they added at the press conference.
Prior ATA guidelines, in place since 2009, called for near-total or total thyroidectomy for cancers that were at least 1 cm in size in patients with no contraindications to the procedure. The 2015 update says the initial surgical procedure could also be a unilateral procedure, or lobectomy, in cancers greater than 1 cm, or smaller than 4 cm with no extrathyroidal extension.
Dr. Ullmann and Dr. Beninato had no relevant financial relationships with commercial interests pertaining to the content of their presentation.
SOURCE: Ullmann TM et al. Abstract SF121 presented at the American College of Surgeons Clinical Congress.
BOSTON – that position the procedure as equivalent to total thyroidectomy, an analysis of U.S. hospital data shows.
Patients undergoing hemithyroidectomy had fewer complications and shorter length of stay versus patients who received a bilateral procedure, with no corresponding increase in completion thyroidectomy, according to results of the retrospective analysis reported here at the annual clinical congress of the American College of Surgeons.
“We think this suggests that surgeons might be changing their practice at these hospitals, at least in part in response to the guidelines,” investigator Timothy M. Ullmann, MD, endocrine oncology research fellow in the department of surgery at New York Presbyterian Hospital–Weill Cornell Medical Center, New York.
Dr. Ullmann and colleagues queried the American College of Surgeons National Surgical Quality Improvement Program database for the 2014-2016 period to illustrate operative trends before and after release of the 2015 guidelines from the American Thyroid Association guidelines. They looked at a total of 26,562 procedures done before the guidelines were release, and 7,422 done after.
The rate of hemithyroidectomy increased from 15.6% before guidelines to 18.3% afterward (P less than .001), according to Dr. Ullmann. By contrast, the rates of completion thyroidectomy were 7.8% for the pre-guidelines period and 7.4% post-guidelines (P = .19).
The increase was gradual throughout the 2014-2016 period, though it was especially steep after the guideline introduction, according to co-investigator Toni Beninato, MD, of Weill Cornell Medicine.
“While we can’t say that the guidelines directly caused an increase, it’s a pretty good association,” Dr. Beninato said in a press conference. “I think going forward, we would expect this to continue to increase, because the vast majority of patients with thyroid cancer probably fit criteria to have a hemithyroidectomy rather than a total thyroidectomy.”
Patients treated by otolaryngologists were more likely to undergo hemithyroidectomies versus those treated by general surgeons, multivariate analysis of this data set suggested (odds ratio, 1.13, P less than .001). On the other hand, Hispanic patients and those with a higher operative risk classification were less likely to undergo a unilateral procedure.
Complications were less likely in the hemithyroidectomy patients, according to investigators. There were significantly fewer superficial surgical site infections, at 0.2% versus 0.4% for total thyroidectomy, and operative time was 91.6 minutes versus 141.1 minutes.
Hemithyroidectomy patients were less likely to be reintubated after surgery, had a shorter length of stay, and were more likely to be managed on an outpatient basis, they added at the press conference.
Prior ATA guidelines, in place since 2009, called for near-total or total thyroidectomy for cancers that were at least 1 cm in size in patients with no contraindications to the procedure. The 2015 update says the initial surgical procedure could also be a unilateral procedure, or lobectomy, in cancers greater than 1 cm, or smaller than 4 cm with no extrathyroidal extension.
Dr. Ullmann and Dr. Beninato had no relevant financial relationships with commercial interests pertaining to the content of their presentation.
SOURCE: Ullmann TM et al. Abstract SF121 presented at the American College of Surgeons Clinical Congress.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Hemithyroidectomy rates had a robust uptick following release of 2015 clinical practice guidelines, suggesting surgeons may be changing their practice in response.
Major finding: The rate of hemithyroidectomy increased from 15.6% before guidelines to 18.3% afterward (P < 0.001).
Study details: Analysis of the American College of Surgeons-NSQIP database from 2014 to 2016 including nearly 34,000 procedures.
Disclosures: Study authors reported no disclosures.
Source: Ullmann TM et al. Abstract SF125 presented at American College of Surgeons Clinical Congress
Survey: Humanitarian surgical groups need best-practices guidelines
BOSTON – A survey of U.S. and suggests that a best-practices guide would be beneficial in helping them adhere more closely to standard protocols.
While most NGOs follow guideline-based practices, some deviations from standard of care do occur. Deviations occurred most often in the areas of preoperative workup, operative technique, and pain management, according to survey results presented at the annual clinical congress of the American College of Surgeons.
Consensus guidelines specific to the NGO sector would be used by the great majority of NGOs surveyed, reported Peter F. Johnston, MD, a general surgery resident and the Ben Rush Global Surgery Fellow at Rutgers New Jersey Medical School.
“There is a lot of heterogeneity in the sector, based on the different organizations doing general surgery and organizations doing plastics,” Dr. Johnston said in an interview. “What we think we can do in terms of low-hanging fruit is come up with guidelines for things like perioperative antibiotics that are pretty much common to all types of surgeries.”
The survey conducted by Dr. Johnston and colleagues is one of the first to characterize the clinical practices of U.S. humanitarian organizations that provide general or subspecialty care through short-term surgical missions. It was completed by representatives of 30 of 83 organizations (36%) that were contacted.
Of respondents, 20% said their organizations deviated from standard U.S. practice often or very often, Dr. Johnston said in his presentation. The respondents mentioned deviation from standard practice in pain management (18%), preoperative workup (16%), and operative technique (16%).
Only about one-third of respondents said they believed those deviations impacted patient outcomes, the results show.
In all, 67% of respondents adhered to at least four protocol-driven practices. Those NGOs that adhered most closely to standard protocol tended to be older, more established organizations, compared with those less protocolized organizations, according to Dr. Johnston (age of organization 22 vs. 14 years, P < .05).
“It makes sense... from my own experience of going back to the same countries,” said Dr. Johnston, who has participated in missions in countries including Ghana, Sierra Leone, and Peru. “As an organization, and even within different countries, the process gets smoother as you keep working at it.”
A total of 85% of respondents expressed interest in best-practice guidelines to guide short-term surgical missions, according to the survey data.
Dr. Johnston reported no conflicts of interest related to his presentation.
SOURCE: Johnston P, et al. Abstract SF121 presented at the American College of Surgeons Clinical Congress.
BOSTON – A survey of U.S. and suggests that a best-practices guide would be beneficial in helping them adhere more closely to standard protocols.
While most NGOs follow guideline-based practices, some deviations from standard of care do occur. Deviations occurred most often in the areas of preoperative workup, operative technique, and pain management, according to survey results presented at the annual clinical congress of the American College of Surgeons.
Consensus guidelines specific to the NGO sector would be used by the great majority of NGOs surveyed, reported Peter F. Johnston, MD, a general surgery resident and the Ben Rush Global Surgery Fellow at Rutgers New Jersey Medical School.
“There is a lot of heterogeneity in the sector, based on the different organizations doing general surgery and organizations doing plastics,” Dr. Johnston said in an interview. “What we think we can do in terms of low-hanging fruit is come up with guidelines for things like perioperative antibiotics that are pretty much common to all types of surgeries.”
The survey conducted by Dr. Johnston and colleagues is one of the first to characterize the clinical practices of U.S. humanitarian organizations that provide general or subspecialty care through short-term surgical missions. It was completed by representatives of 30 of 83 organizations (36%) that were contacted.
Of respondents, 20% said their organizations deviated from standard U.S. practice often or very often, Dr. Johnston said in his presentation. The respondents mentioned deviation from standard practice in pain management (18%), preoperative workup (16%), and operative technique (16%).
Only about one-third of respondents said they believed those deviations impacted patient outcomes, the results show.
In all, 67% of respondents adhered to at least four protocol-driven practices. Those NGOs that adhered most closely to standard protocol tended to be older, more established organizations, compared with those less protocolized organizations, according to Dr. Johnston (age of organization 22 vs. 14 years, P < .05).
“It makes sense... from my own experience of going back to the same countries,” said Dr. Johnston, who has participated in missions in countries including Ghana, Sierra Leone, and Peru. “As an organization, and even within different countries, the process gets smoother as you keep working at it.”
A total of 85% of respondents expressed interest in best-practice guidelines to guide short-term surgical missions, according to the survey data.
Dr. Johnston reported no conflicts of interest related to his presentation.
SOURCE: Johnston P, et al. Abstract SF121 presented at the American College of Surgeons Clinical Congress.
BOSTON – A survey of U.S. and suggests that a best-practices guide would be beneficial in helping them adhere more closely to standard protocols.
While most NGOs follow guideline-based practices, some deviations from standard of care do occur. Deviations occurred most often in the areas of preoperative workup, operative technique, and pain management, according to survey results presented at the annual clinical congress of the American College of Surgeons.
Consensus guidelines specific to the NGO sector would be used by the great majority of NGOs surveyed, reported Peter F. Johnston, MD, a general surgery resident and the Ben Rush Global Surgery Fellow at Rutgers New Jersey Medical School.
“There is a lot of heterogeneity in the sector, based on the different organizations doing general surgery and organizations doing plastics,” Dr. Johnston said in an interview. “What we think we can do in terms of low-hanging fruit is come up with guidelines for things like perioperative antibiotics that are pretty much common to all types of surgeries.”
The survey conducted by Dr. Johnston and colleagues is one of the first to characterize the clinical practices of U.S. humanitarian organizations that provide general or subspecialty care through short-term surgical missions. It was completed by representatives of 30 of 83 organizations (36%) that were contacted.
Of respondents, 20% said their organizations deviated from standard U.S. practice often or very often, Dr. Johnston said in his presentation. The respondents mentioned deviation from standard practice in pain management (18%), preoperative workup (16%), and operative technique (16%).
Only about one-third of respondents said they believed those deviations impacted patient outcomes, the results show.
In all, 67% of respondents adhered to at least four protocol-driven practices. Those NGOs that adhered most closely to standard protocol tended to be older, more established organizations, compared with those less protocolized organizations, according to Dr. Johnston (age of organization 22 vs. 14 years, P < .05).
“It makes sense... from my own experience of going back to the same countries,” said Dr. Johnston, who has participated in missions in countries including Ghana, Sierra Leone, and Peru. “As an organization, and even within different countries, the process gets smoother as you keep working at it.”
A total of 85% of respondents expressed interest in best-practice guidelines to guide short-term surgical missions, according to the survey data.
Dr. Johnston reported no conflicts of interest related to his presentation.
SOURCE: Johnston P, et al. Abstract SF121 presented at the American College of Surgeons Clinical Congress.
AT THE ACS CLINICAL CONGRESS
Key clinical point: The clinical practice of some humanitarian surgical organizations deviated from standard practice, suggesting a need for NGO-specific guidelines.
Major finding: The most common deviations from standard practice were in pain management (18%), preoperative workup (16%), and operative technique (16%).
Study details: 30 Responses from a survey of 83 organizations that provide general or subspecialty care through short-term surgical missions.
Disclosures: Study authors reported no conflicts.
Source: Johnston PF et al. Abstract SF121 presented at the American College of Surgeons Clinical Congress.
Septic shock: Innovative treatment options in the wings
BOSTON– treatment that require more investigation, but nevertheless appear promising, Rishi Rattan, MD, said at the annual clinical congress of the American College of Surgeons.
Trials evaluating vitamin C in this setting have demonstrated a large mortality impact with an absence of side effects, according to Dr. Rattan, a trauma and critical care surgeon with the Ryder Trauma Center at the University of Miami.
“It’s something that I have decided to start early adopting, and many of my colleagues at University of Miami do as well,” Dr. Rattan said in a panel session on updates in septic shock. “We’re anecdotally so far at least seeing good results and are going to be excited to see what these ongoing trials show.”
As an antioxidant, vitamin C has anti-inflammatory properties that may possibly attenuate the overly exuberant inflammatory response seen in septic shock, Dr. Rattan said in his presentation.
The limited clinical data for vitamin C in refractory shock include three studies, of which two are randomized controlled trials, comprising a total of 146 patients, he added.
“I will admit an N of 146 is hardly practice-changing for most people,” Dr. Rattan said. “There’s still a significant and sustained large mortality effect for the use of vitamin C, with nearly no adverse effects.”
Pooled analysis of all three studies revealed a marked reduction in mortality with the use of vitamin C (odds ratio, 0.17, 95% confidence interval 0.07–0.40; P less than .001), according to a meta-analysis recently just published in Critical Care that Dr. Rattan referenced in his presentation (Critical Care 2018;22:258, DOI:10.1186/s13054-018-2191-x).
When taken in recommended dosages, vitamin C given with corticosteroids and thiamine is without known side effects, researcher Paul E. Marik wrote earlier this year in an editorial in Pharmacology & Therapeutics (2018;189[9]:63-70, DOI:10.1016/j.pharmthera.2018.04.007) noted Dr. Rattan, who said he uses the intravenous vitamin C, thiamine, and hydrocortisone protocol previously reported by Dr. Marik and colleagues.
There are 13 ongoing trials, including some prospective blinded, randomized trials, looking at the role of vitamin C in refractory shock, he added.
Angiotensin-II is another intervention that may be promising in refractory septic shock, Dr. Rattan told attendees, pointing to the 2017 publication of the ATHOS-3 trial in the New England Journal of Medicine (2017; 377:419-430,DOI: 10.1056/NEJMoa1704154) showing that treatment increased blood pressure in patients with vasodilatory shock not responding to conventional vasopressors at high doses.
Likewise, methylene blue has shown promise in septic shock, at least in some limited clinical investigations and anecdotally in patients not improving despite standard interventions. “I’ve been able to have a couple patients walk out of the hospital with the use of methylene blue,” Dr. Rattan said. “Again, the plural of ‘anecdote’ is not ‘data,’ but it’s something to consider for the early adopters.”
Dr. Rattan had no disclosures related to his presentation.
BOSTON– treatment that require more investigation, but nevertheless appear promising, Rishi Rattan, MD, said at the annual clinical congress of the American College of Surgeons.
Trials evaluating vitamin C in this setting have demonstrated a large mortality impact with an absence of side effects, according to Dr. Rattan, a trauma and critical care surgeon with the Ryder Trauma Center at the University of Miami.
“It’s something that I have decided to start early adopting, and many of my colleagues at University of Miami do as well,” Dr. Rattan said in a panel session on updates in septic shock. “We’re anecdotally so far at least seeing good results and are going to be excited to see what these ongoing trials show.”
As an antioxidant, vitamin C has anti-inflammatory properties that may possibly attenuate the overly exuberant inflammatory response seen in septic shock, Dr. Rattan said in his presentation.
The limited clinical data for vitamin C in refractory shock include three studies, of which two are randomized controlled trials, comprising a total of 146 patients, he added.
“I will admit an N of 146 is hardly practice-changing for most people,” Dr. Rattan said. “There’s still a significant and sustained large mortality effect for the use of vitamin C, with nearly no adverse effects.”
Pooled analysis of all three studies revealed a marked reduction in mortality with the use of vitamin C (odds ratio, 0.17, 95% confidence interval 0.07–0.40; P less than .001), according to a meta-analysis recently just published in Critical Care that Dr. Rattan referenced in his presentation (Critical Care 2018;22:258, DOI:10.1186/s13054-018-2191-x).
When taken in recommended dosages, vitamin C given with corticosteroids and thiamine is without known side effects, researcher Paul E. Marik wrote earlier this year in an editorial in Pharmacology & Therapeutics (2018;189[9]:63-70, DOI:10.1016/j.pharmthera.2018.04.007) noted Dr. Rattan, who said he uses the intravenous vitamin C, thiamine, and hydrocortisone protocol previously reported by Dr. Marik and colleagues.
There are 13 ongoing trials, including some prospective blinded, randomized trials, looking at the role of vitamin C in refractory shock, he added.
Angiotensin-II is another intervention that may be promising in refractory septic shock, Dr. Rattan told attendees, pointing to the 2017 publication of the ATHOS-3 trial in the New England Journal of Medicine (2017; 377:419-430,DOI: 10.1056/NEJMoa1704154) showing that treatment increased blood pressure in patients with vasodilatory shock not responding to conventional vasopressors at high doses.
Likewise, methylene blue has shown promise in septic shock, at least in some limited clinical investigations and anecdotally in patients not improving despite standard interventions. “I’ve been able to have a couple patients walk out of the hospital with the use of methylene blue,” Dr. Rattan said. “Again, the plural of ‘anecdote’ is not ‘data,’ but it’s something to consider for the early adopters.”
Dr. Rattan had no disclosures related to his presentation.
BOSTON– treatment that require more investigation, but nevertheless appear promising, Rishi Rattan, MD, said at the annual clinical congress of the American College of Surgeons.
Trials evaluating vitamin C in this setting have demonstrated a large mortality impact with an absence of side effects, according to Dr. Rattan, a trauma and critical care surgeon with the Ryder Trauma Center at the University of Miami.
“It’s something that I have decided to start early adopting, and many of my colleagues at University of Miami do as well,” Dr. Rattan said in a panel session on updates in septic shock. “We’re anecdotally so far at least seeing good results and are going to be excited to see what these ongoing trials show.”
As an antioxidant, vitamin C has anti-inflammatory properties that may possibly attenuate the overly exuberant inflammatory response seen in septic shock, Dr. Rattan said in his presentation.
The limited clinical data for vitamin C in refractory shock include three studies, of which two are randomized controlled trials, comprising a total of 146 patients, he added.
“I will admit an N of 146 is hardly practice-changing for most people,” Dr. Rattan said. “There’s still a significant and sustained large mortality effect for the use of vitamin C, with nearly no adverse effects.”
Pooled analysis of all three studies revealed a marked reduction in mortality with the use of vitamin C (odds ratio, 0.17, 95% confidence interval 0.07–0.40; P less than .001), according to a meta-analysis recently just published in Critical Care that Dr. Rattan referenced in his presentation (Critical Care 2018;22:258, DOI:10.1186/s13054-018-2191-x).
When taken in recommended dosages, vitamin C given with corticosteroids and thiamine is without known side effects, researcher Paul E. Marik wrote earlier this year in an editorial in Pharmacology & Therapeutics (2018;189[9]:63-70, DOI:10.1016/j.pharmthera.2018.04.007) noted Dr. Rattan, who said he uses the intravenous vitamin C, thiamine, and hydrocortisone protocol previously reported by Dr. Marik and colleagues.
There are 13 ongoing trials, including some prospective blinded, randomized trials, looking at the role of vitamin C in refractory shock, he added.
Angiotensin-II is another intervention that may be promising in refractory septic shock, Dr. Rattan told attendees, pointing to the 2017 publication of the ATHOS-3 trial in the New England Journal of Medicine (2017; 377:419-430,DOI: 10.1056/NEJMoa1704154) showing that treatment increased blood pressure in patients with vasodilatory shock not responding to conventional vasopressors at high doses.
Likewise, methylene blue has shown promise in septic shock, at least in some limited clinical investigations and anecdotally in patients not improving despite standard interventions. “I’ve been able to have a couple patients walk out of the hospital with the use of methylene blue,” Dr. Rattan said. “Again, the plural of ‘anecdote’ is not ‘data,’ but it’s something to consider for the early adopters.”
Dr. Rattan had no disclosures related to his presentation.
AT THE ACS CLINICAL CONGRESS
Improved treatments emerge for hemophilia patients with high-titer inhibitors
For patients with hemophilia and high-titer inhibitors, a new era of treatment has begun with the development of improved variants of traditional bypassing agents and novel, nonfactor-based, prophylactic agents, say authors of a recent review article.
“These new agents may transform the treatment of inhibitor patients and inhibitor-related bleeds, potentially decreasing morbidity and mortality and improving patients’ quality of life,” Amy D. Shapiro, MD, and coauthors wrote in the Journal of Thrombosis and Haemostasis.
Until recently, the only two bypassing agents available were activated prothrombin complex concentrates and recombinant factor VIIa, noted Dr. Shapiro, who is CEO and co-medical director of the Indiana Hemophilia and Thrombosis Center, Indianapolis, and her coauthors.
The first of the novel targeted agents, emicizumab, is a humanized, bispecific monoclonal antibody that was approved for prophylactic use in hemophilia A in the United States in November 2017.
Emicizumab could transform the treatment of patients with inhibitors, but it also requires reconsideration of how to treat breakthrough bleeds and eliminate the underlying inhibitor, the authors said.
In a phase 3 study, this biologic significantly decreased the annualized bleeding rate by 87% versus on-demand bypassing agent therapy, and by 79% versus a prophylactic bypassing agent regimen, they said, noting that 63% of patients had no bleeding events during the study.
Serious adverse events were seen in patients receiving emicizumab prophylaxis, including thrombosis in 2 out of 103 subjects and thrombotic microangiopathy in 3. In all cases, the patients were treating breakthrough bleeds with activated prothrombin complex concentrate, Dr. Shapiro and coauthors wrote.
Other novel agents in clinical development include fitusiran and tissue factor pathway inhibitors, which each target a different natural anticoagulant and could result in new prophylactic options, according to the study coauthors.
“The possibility of multiple therapeutic targets may allow for a highly personalized approach to prophylaxis therapy, with traditional bypassing agents providing options when breakthrough bleeds occur,” they wrote.
In the meantime, eptacog alfa is the “de facto standard” for recombinant factor VIIa, though a new variant under development, eptacog beta, has been accepted for regulatory review in the United States. In a phase 3 clinical trial, eptacog beta appeared to provide improved efficacy and decreased dosing requirements, possibly due to increased binding affinity to endothelial protein C receptor (EPCR), the authors said.
“The addition of improved rFVIIa variants with unique pharmacological and pharmacokinetic profiles will provide new tools to treat bleeding events in inhibitor patients,” Dr. Shapiro and her colleagues wrote.
The use of traditional bypassing agents is expected to decrease over time as new and improved therapeutics are developed. Traditional agents, however, will “remain a necessity” for breakthrough bleeds in hemophilia A patients with inhibitors, and until novel agents become available for hemophilia B, the authors said.
The review article was supported by an unrestricted educational grant from HEMA Biologics, LLC, which had no involvement or editorial control in research, writing or submission. Dr. Shapiro reported disclosures related to HEMA Biologics, Shire, Novo Nordisk, Kedrion Biopharma, Bioverativ, and Genentech.
SOURCE: Shapiro AD, et al. J Thromb Haemost. 2018 Sep 28.
For patients with hemophilia and high-titer inhibitors, a new era of treatment has begun with the development of improved variants of traditional bypassing agents and novel, nonfactor-based, prophylactic agents, say authors of a recent review article.
“These new agents may transform the treatment of inhibitor patients and inhibitor-related bleeds, potentially decreasing morbidity and mortality and improving patients’ quality of life,” Amy D. Shapiro, MD, and coauthors wrote in the Journal of Thrombosis and Haemostasis.
Until recently, the only two bypassing agents available were activated prothrombin complex concentrates and recombinant factor VIIa, noted Dr. Shapiro, who is CEO and co-medical director of the Indiana Hemophilia and Thrombosis Center, Indianapolis, and her coauthors.
The first of the novel targeted agents, emicizumab, is a humanized, bispecific monoclonal antibody that was approved for prophylactic use in hemophilia A in the United States in November 2017.
Emicizumab could transform the treatment of patients with inhibitors, but it also requires reconsideration of how to treat breakthrough bleeds and eliminate the underlying inhibitor, the authors said.
In a phase 3 study, this biologic significantly decreased the annualized bleeding rate by 87% versus on-demand bypassing agent therapy, and by 79% versus a prophylactic bypassing agent regimen, they said, noting that 63% of patients had no bleeding events during the study.
Serious adverse events were seen in patients receiving emicizumab prophylaxis, including thrombosis in 2 out of 103 subjects and thrombotic microangiopathy in 3. In all cases, the patients were treating breakthrough bleeds with activated prothrombin complex concentrate, Dr. Shapiro and coauthors wrote.
Other novel agents in clinical development include fitusiran and tissue factor pathway inhibitors, which each target a different natural anticoagulant and could result in new prophylactic options, according to the study coauthors.
“The possibility of multiple therapeutic targets may allow for a highly personalized approach to prophylaxis therapy, with traditional bypassing agents providing options when breakthrough bleeds occur,” they wrote.
In the meantime, eptacog alfa is the “de facto standard” for recombinant factor VIIa, though a new variant under development, eptacog beta, has been accepted for regulatory review in the United States. In a phase 3 clinical trial, eptacog beta appeared to provide improved efficacy and decreased dosing requirements, possibly due to increased binding affinity to endothelial protein C receptor (EPCR), the authors said.
“The addition of improved rFVIIa variants with unique pharmacological and pharmacokinetic profiles will provide new tools to treat bleeding events in inhibitor patients,” Dr. Shapiro and her colleagues wrote.
The use of traditional bypassing agents is expected to decrease over time as new and improved therapeutics are developed. Traditional agents, however, will “remain a necessity” for breakthrough bleeds in hemophilia A patients with inhibitors, and until novel agents become available for hemophilia B, the authors said.
The review article was supported by an unrestricted educational grant from HEMA Biologics, LLC, which had no involvement or editorial control in research, writing or submission. Dr. Shapiro reported disclosures related to HEMA Biologics, Shire, Novo Nordisk, Kedrion Biopharma, Bioverativ, and Genentech.
SOURCE: Shapiro AD, et al. J Thromb Haemost. 2018 Sep 28.
For patients with hemophilia and high-titer inhibitors, a new era of treatment has begun with the development of improved variants of traditional bypassing agents and novel, nonfactor-based, prophylactic agents, say authors of a recent review article.
“These new agents may transform the treatment of inhibitor patients and inhibitor-related bleeds, potentially decreasing morbidity and mortality and improving patients’ quality of life,” Amy D. Shapiro, MD, and coauthors wrote in the Journal of Thrombosis and Haemostasis.
Until recently, the only two bypassing agents available were activated prothrombin complex concentrates and recombinant factor VIIa, noted Dr. Shapiro, who is CEO and co-medical director of the Indiana Hemophilia and Thrombosis Center, Indianapolis, and her coauthors.
The first of the novel targeted agents, emicizumab, is a humanized, bispecific monoclonal antibody that was approved for prophylactic use in hemophilia A in the United States in November 2017.
Emicizumab could transform the treatment of patients with inhibitors, but it also requires reconsideration of how to treat breakthrough bleeds and eliminate the underlying inhibitor, the authors said.
In a phase 3 study, this biologic significantly decreased the annualized bleeding rate by 87% versus on-demand bypassing agent therapy, and by 79% versus a prophylactic bypassing agent regimen, they said, noting that 63% of patients had no bleeding events during the study.
Serious adverse events were seen in patients receiving emicizumab prophylaxis, including thrombosis in 2 out of 103 subjects and thrombotic microangiopathy in 3. In all cases, the patients were treating breakthrough bleeds with activated prothrombin complex concentrate, Dr. Shapiro and coauthors wrote.
Other novel agents in clinical development include fitusiran and tissue factor pathway inhibitors, which each target a different natural anticoagulant and could result in new prophylactic options, according to the study coauthors.
“The possibility of multiple therapeutic targets may allow for a highly personalized approach to prophylaxis therapy, with traditional bypassing agents providing options when breakthrough bleeds occur,” they wrote.
In the meantime, eptacog alfa is the “de facto standard” for recombinant factor VIIa, though a new variant under development, eptacog beta, has been accepted for regulatory review in the United States. In a phase 3 clinical trial, eptacog beta appeared to provide improved efficacy and decreased dosing requirements, possibly due to increased binding affinity to endothelial protein C receptor (EPCR), the authors said.
“The addition of improved rFVIIa variants with unique pharmacological and pharmacokinetic profiles will provide new tools to treat bleeding events in inhibitor patients,” Dr. Shapiro and her colleagues wrote.
The use of traditional bypassing agents is expected to decrease over time as new and improved therapeutics are developed. Traditional agents, however, will “remain a necessity” for breakthrough bleeds in hemophilia A patients with inhibitors, and until novel agents become available for hemophilia B, the authors said.
The review article was supported by an unrestricted educational grant from HEMA Biologics, LLC, which had no involvement or editorial control in research, writing or submission. Dr. Shapiro reported disclosures related to HEMA Biologics, Shire, Novo Nordisk, Kedrion Biopharma, Bioverativ, and Genentech.
SOURCE: Shapiro AD, et al. J Thromb Haemost. 2018 Sep 28.
FROM THE JOURNAL OF THROMBOSIS AND HAEMOSTASIS
Algorithm helps assess surgical trade-offs of hernia repair
BOSTON – Choosing an operative approach for ventral hernia can be a matter of weighing the trade-offs between infection risk, postop quality of life, and patient and defect characteristics. A predictive algorithm has been developed to help with this decision, according to a study presented at the annual clinical congress of the American College of Surgeons.
Predictive modeling indicates that open repair might be considered, for example, in low BMI patients with large defects because of potentially fewer anticipated complications and improved quality of life, according to authors of the study. Conversely, laparoscopic repair might be considered in high BMI patients with recurrent hernias to decrease the associated risk of infection, the authors noted in a published abstract of the study.
The retrospective study was based on data on ventral hernia repairs in the International Hernia Mesh Registry that were performed between 2007 and 2017. Investigators used that data to build a predictive algorithm that took into account the impact on outcomes of BMI, hernia size, and operative approach, as well as age, sex, and diabetes status.
They identified 1,906 repairs, of which about 60% were open procedures. The mean patient age was 54.9 years, while mean BMI was 31.2 kg/m2 and the mean defect area was 44.8 cm2. Patients undergoing open procedures were significantly more likely to have infections, at 3.1% versus 0.3% for the laparoscopic approach (P less than .0001), investigators found.
A multivariate regression analysis controlling for confounding variables found that patients undergoing laparoscopic repair had an increased risk of seroma (odds ratio 1.78, confidence interval 1.05-3.03) but a decreased risk of infection (OR 0.05, CI 0.01-0.42). In addition, those undergoing laparoscopic procedures were more likely to have non-ideal quality of life at 1, 6, 12, and 24 months postoperatively, said the study’s lead author, Kathryn A. Schlosser, MD, a resident in the division of gastrointestinal and minimally invasive surgery, department of surgery, Carolinas Medical Center, Charlotte, N.C.
“These are both important factors — infection and non-ideal quality of life — and need to be part of our preoperative discussion with our patients when we start managing their expectations around the time of surgery,” Dr. Schlosser said in a podium presentation.
She and her colleagues calculated probability of infection based on the ratio of BMI to defect area. They found that, for example, the probability of postoperative infection was 21% for a diabetic 69-year-old female with a recurrent hernia who had a BMI of 39 and a defect area of 20 cm2. By contrast, infection probability was 3% in a 66-year-old female with a BMI of 37, a defect area of 1 cm2, and no diabetes, Dr. Schlosser said at the meeting.
Laparoscopic versus open procedures represented a trade-off between infection risk and quality of life in this algorithm. For patients at medium risk for infection based on BMI, defect size, and other variables, switching to a laparoscopic approach dropped the infection probability from 3%-8% down to 0.1%-0.5%, Dr. Schlosser told attendees. On the other hand, switching to a laparoscopic approach increased the risk of non-ideal quality of life, she said.
One sample patient Dr. Schlosser described had an infection risk of 7.2% with the open procedure that dropped to just 0.4% for the laparoscopic procedure; however, that switch would mean that her likelihood of non-ideal quality of life 12 months after surgery increased from 24% with the open repair to 44% with the laparoscopic repair.
Dr. Schlosser had no disclosures related to the study. Co-authors provided disclosures related to Acelity, Allergan, Intuitive, Stryker, and W.L. Gore.
SOURCE: Schlosser KA, et al. abstract SF215 presented at the American College of Surgeons Clinical Congress 2018.
BOSTON – Choosing an operative approach for ventral hernia can be a matter of weighing the trade-offs between infection risk, postop quality of life, and patient and defect characteristics. A predictive algorithm has been developed to help with this decision, according to a study presented at the annual clinical congress of the American College of Surgeons.
Predictive modeling indicates that open repair might be considered, for example, in low BMI patients with large defects because of potentially fewer anticipated complications and improved quality of life, according to authors of the study. Conversely, laparoscopic repair might be considered in high BMI patients with recurrent hernias to decrease the associated risk of infection, the authors noted in a published abstract of the study.
The retrospective study was based on data on ventral hernia repairs in the International Hernia Mesh Registry that were performed between 2007 and 2017. Investigators used that data to build a predictive algorithm that took into account the impact on outcomes of BMI, hernia size, and operative approach, as well as age, sex, and diabetes status.
They identified 1,906 repairs, of which about 60% were open procedures. The mean patient age was 54.9 years, while mean BMI was 31.2 kg/m2 and the mean defect area was 44.8 cm2. Patients undergoing open procedures were significantly more likely to have infections, at 3.1% versus 0.3% for the laparoscopic approach (P less than .0001), investigators found.
A multivariate regression analysis controlling for confounding variables found that patients undergoing laparoscopic repair had an increased risk of seroma (odds ratio 1.78, confidence interval 1.05-3.03) but a decreased risk of infection (OR 0.05, CI 0.01-0.42). In addition, those undergoing laparoscopic procedures were more likely to have non-ideal quality of life at 1, 6, 12, and 24 months postoperatively, said the study’s lead author, Kathryn A. Schlosser, MD, a resident in the division of gastrointestinal and minimally invasive surgery, department of surgery, Carolinas Medical Center, Charlotte, N.C.
“These are both important factors — infection and non-ideal quality of life — and need to be part of our preoperative discussion with our patients when we start managing their expectations around the time of surgery,” Dr. Schlosser said in a podium presentation.
She and her colleagues calculated probability of infection based on the ratio of BMI to defect area. They found that, for example, the probability of postoperative infection was 21% for a diabetic 69-year-old female with a recurrent hernia who had a BMI of 39 and a defect area of 20 cm2. By contrast, infection probability was 3% in a 66-year-old female with a BMI of 37, a defect area of 1 cm2, and no diabetes, Dr. Schlosser said at the meeting.
Laparoscopic versus open procedures represented a trade-off between infection risk and quality of life in this algorithm. For patients at medium risk for infection based on BMI, defect size, and other variables, switching to a laparoscopic approach dropped the infection probability from 3%-8% down to 0.1%-0.5%, Dr. Schlosser told attendees. On the other hand, switching to a laparoscopic approach increased the risk of non-ideal quality of life, she said.
One sample patient Dr. Schlosser described had an infection risk of 7.2% with the open procedure that dropped to just 0.4% for the laparoscopic procedure; however, that switch would mean that her likelihood of non-ideal quality of life 12 months after surgery increased from 24% with the open repair to 44% with the laparoscopic repair.
Dr. Schlosser had no disclosures related to the study. Co-authors provided disclosures related to Acelity, Allergan, Intuitive, Stryker, and W.L. Gore.
SOURCE: Schlosser KA, et al. abstract SF215 presented at the American College of Surgeons Clinical Congress 2018.
BOSTON – Choosing an operative approach for ventral hernia can be a matter of weighing the trade-offs between infection risk, postop quality of life, and patient and defect characteristics. A predictive algorithm has been developed to help with this decision, according to a study presented at the annual clinical congress of the American College of Surgeons.
Predictive modeling indicates that open repair might be considered, for example, in low BMI patients with large defects because of potentially fewer anticipated complications and improved quality of life, according to authors of the study. Conversely, laparoscopic repair might be considered in high BMI patients with recurrent hernias to decrease the associated risk of infection, the authors noted in a published abstract of the study.
The retrospective study was based on data on ventral hernia repairs in the International Hernia Mesh Registry that were performed between 2007 and 2017. Investigators used that data to build a predictive algorithm that took into account the impact on outcomes of BMI, hernia size, and operative approach, as well as age, sex, and diabetes status.
They identified 1,906 repairs, of which about 60% were open procedures. The mean patient age was 54.9 years, while mean BMI was 31.2 kg/m2 and the mean defect area was 44.8 cm2. Patients undergoing open procedures were significantly more likely to have infections, at 3.1% versus 0.3% for the laparoscopic approach (P less than .0001), investigators found.
A multivariate regression analysis controlling for confounding variables found that patients undergoing laparoscopic repair had an increased risk of seroma (odds ratio 1.78, confidence interval 1.05-3.03) but a decreased risk of infection (OR 0.05, CI 0.01-0.42). In addition, those undergoing laparoscopic procedures were more likely to have non-ideal quality of life at 1, 6, 12, and 24 months postoperatively, said the study’s lead author, Kathryn A. Schlosser, MD, a resident in the division of gastrointestinal and minimally invasive surgery, department of surgery, Carolinas Medical Center, Charlotte, N.C.
“These are both important factors — infection and non-ideal quality of life — and need to be part of our preoperative discussion with our patients when we start managing their expectations around the time of surgery,” Dr. Schlosser said in a podium presentation.
She and her colleagues calculated probability of infection based on the ratio of BMI to defect area. They found that, for example, the probability of postoperative infection was 21% for a diabetic 69-year-old female with a recurrent hernia who had a BMI of 39 and a defect area of 20 cm2. By contrast, infection probability was 3% in a 66-year-old female with a BMI of 37, a defect area of 1 cm2, and no diabetes, Dr. Schlosser said at the meeting.
Laparoscopic versus open procedures represented a trade-off between infection risk and quality of life in this algorithm. For patients at medium risk for infection based on BMI, defect size, and other variables, switching to a laparoscopic approach dropped the infection probability from 3%-8% down to 0.1%-0.5%, Dr. Schlosser told attendees. On the other hand, switching to a laparoscopic approach increased the risk of non-ideal quality of life, she said.
One sample patient Dr. Schlosser described had an infection risk of 7.2% with the open procedure that dropped to just 0.4% for the laparoscopic procedure; however, that switch would mean that her likelihood of non-ideal quality of life 12 months after surgery increased from 24% with the open repair to 44% with the laparoscopic repair.
Dr. Schlosser had no disclosures related to the study. Co-authors provided disclosures related to Acelity, Allergan, Intuitive, Stryker, and W.L. Gore.
SOURCE: Schlosser KA, et al. abstract SF215 presented at the American College of Surgeons Clinical Congress 2018.
REPORTING FROM THE ACS CLINICAL CONGRESS
Key clinical point: BMI and defect size are key factors for choosing laparoscopic or open surgery for ventral hernia repair.
Major finding: Patients undergoing open procedures were significantly more likely to have infections, at 3.1% versus 0.3% for the laparoscopic approach.
Study details: Retrospective study including 1,906 ventral hernia repairs in the International Hernia Mesh Registry conducted between 2007 and 2017.
Disclosures: Study authors provided disclosures related to Acelity, Allergan, Intuitive, Stryker, and W.L. Gore.
Source: Schlosser KA, et al. abstract SF215 presented at the American College of Surgeons Clinical Congress 2018.
EHR-guided strategy reduces postop VTE events
BOSTON – Avoiding could result in a reduction in VTE rates, a speaker said at the annual clinical congress of the American College of Surgeons.
The VTE rate dropped by about one-quarter in the trauma care pathway at the University of Pittsburgh Medical Center (UPMC) after implementation of algorithms to risk-stratify patients and guide nursing staff, said Matthew D. Neal, MD, FACS, the Roberta G. Simmons Assistant Professor of Surgery at the University of Pittsburgh.
By incorporating algorithms into the electronic health record (EHR), UPMC was able to realize a “dramatic” 72% reduction in missed doses, from 4,331 missed doses in 2014 to 1,193 in 2015, Dr. Neal told attendees in a session focused on hot topics in surgical patient safety.
That decrease in missed doses has translated into a decreased rate of VTE, from an already relatively low rate of 1.5% in 2015, to 1.1% in 2017, representing a 26.7% reduction, according to data Dr. Neal shared in his podium presentation.
“This has been a sustainable event for us, largely linked to the implementation of an EHR-guided risk assessment pathway to guide the implementation of VTE prophylaxis,” he said.
The change was safe, he added, noting that, since utilization of this pathway, there have been no significant increases in the rate of bleeding events among patients who have mandatory orders.
These results corroborate those of some previous investigations, including one key study from the Johns Hopkins Hospital that described the adoption of a mandatory computerized clinical decision support tool to improve adherence to best practices for VTE prophylaxis.
After incorporation of the tool in the computerized order entry system, there was a significant increase in VTE prophylaxis, translating into a significant drop in preventable harm from VTE, from 1.0% to 0.17% (P = .04), investigators reported in JAMA Surgery.
Reducing missed doses is one of the major contributing factors to decreased VTE rates, according to Dr. Neal.
Missed doses of enoxaparin correlate with increased incidence of deep vein thrombosis (DVT) in trauma and general surgery patients, according to results of one prospective study Dr. Neal described. In that study of 202 patients, reported in JAMA Surgery, DVTs were seen in 23.5% of patients with missed doses, compared with 4.8 for patients with no missed doses (P < .01).
“We need to understand how to risk assess and how to utilize our EHR as a tool,” Dr. Neal told attendees.
Dr. Neal reported disclosures related to Janssen Pharmaceuticals, CSL Behring, Accriva Diagnostics, and Haemonetics, as well as a U.S. patent for a treatment of infectious and inflammatory disorders, and laboratory funding from the National Institutes of Health, Department of Defense, and the Biomedical Advanced Research and Development Authority.
SOURCE: Neal MD. Presentation at the American College of Surgeons Clinical Congress. 2018 Oct 25.
BOSTON – Avoiding could result in a reduction in VTE rates, a speaker said at the annual clinical congress of the American College of Surgeons.
The VTE rate dropped by about one-quarter in the trauma care pathway at the University of Pittsburgh Medical Center (UPMC) after implementation of algorithms to risk-stratify patients and guide nursing staff, said Matthew D. Neal, MD, FACS, the Roberta G. Simmons Assistant Professor of Surgery at the University of Pittsburgh.
By incorporating algorithms into the electronic health record (EHR), UPMC was able to realize a “dramatic” 72% reduction in missed doses, from 4,331 missed doses in 2014 to 1,193 in 2015, Dr. Neal told attendees in a session focused on hot topics in surgical patient safety.
That decrease in missed doses has translated into a decreased rate of VTE, from an already relatively low rate of 1.5% in 2015, to 1.1% in 2017, representing a 26.7% reduction, according to data Dr. Neal shared in his podium presentation.
“This has been a sustainable event for us, largely linked to the implementation of an EHR-guided risk assessment pathway to guide the implementation of VTE prophylaxis,” he said.
The change was safe, he added, noting that, since utilization of this pathway, there have been no significant increases in the rate of bleeding events among patients who have mandatory orders.
These results corroborate those of some previous investigations, including one key study from the Johns Hopkins Hospital that described the adoption of a mandatory computerized clinical decision support tool to improve adherence to best practices for VTE prophylaxis.
After incorporation of the tool in the computerized order entry system, there was a significant increase in VTE prophylaxis, translating into a significant drop in preventable harm from VTE, from 1.0% to 0.17% (P = .04), investigators reported in JAMA Surgery.
Reducing missed doses is one of the major contributing factors to decreased VTE rates, according to Dr. Neal.
Missed doses of enoxaparin correlate with increased incidence of deep vein thrombosis (DVT) in trauma and general surgery patients, according to results of one prospective study Dr. Neal described. In that study of 202 patients, reported in JAMA Surgery, DVTs were seen in 23.5% of patients with missed doses, compared with 4.8 for patients with no missed doses (P < .01).
“We need to understand how to risk assess and how to utilize our EHR as a tool,” Dr. Neal told attendees.
Dr. Neal reported disclosures related to Janssen Pharmaceuticals, CSL Behring, Accriva Diagnostics, and Haemonetics, as well as a U.S. patent for a treatment of infectious and inflammatory disorders, and laboratory funding from the National Institutes of Health, Department of Defense, and the Biomedical Advanced Research and Development Authority.
SOURCE: Neal MD. Presentation at the American College of Surgeons Clinical Congress. 2018 Oct 25.
BOSTON – Avoiding could result in a reduction in VTE rates, a speaker said at the annual clinical congress of the American College of Surgeons.
The VTE rate dropped by about one-quarter in the trauma care pathway at the University of Pittsburgh Medical Center (UPMC) after implementation of algorithms to risk-stratify patients and guide nursing staff, said Matthew D. Neal, MD, FACS, the Roberta G. Simmons Assistant Professor of Surgery at the University of Pittsburgh.
By incorporating algorithms into the electronic health record (EHR), UPMC was able to realize a “dramatic” 72% reduction in missed doses, from 4,331 missed doses in 2014 to 1,193 in 2015, Dr. Neal told attendees in a session focused on hot topics in surgical patient safety.
That decrease in missed doses has translated into a decreased rate of VTE, from an already relatively low rate of 1.5% in 2015, to 1.1% in 2017, representing a 26.7% reduction, according to data Dr. Neal shared in his podium presentation.
“This has been a sustainable event for us, largely linked to the implementation of an EHR-guided risk assessment pathway to guide the implementation of VTE prophylaxis,” he said.
The change was safe, he added, noting that, since utilization of this pathway, there have been no significant increases in the rate of bleeding events among patients who have mandatory orders.
These results corroborate those of some previous investigations, including one key study from the Johns Hopkins Hospital that described the adoption of a mandatory computerized clinical decision support tool to improve adherence to best practices for VTE prophylaxis.
After incorporation of the tool in the computerized order entry system, there was a significant increase in VTE prophylaxis, translating into a significant drop in preventable harm from VTE, from 1.0% to 0.17% (P = .04), investigators reported in JAMA Surgery.
Reducing missed doses is one of the major contributing factors to decreased VTE rates, according to Dr. Neal.
Missed doses of enoxaparin correlate with increased incidence of deep vein thrombosis (DVT) in trauma and general surgery patients, according to results of one prospective study Dr. Neal described. In that study of 202 patients, reported in JAMA Surgery, DVTs were seen in 23.5% of patients with missed doses, compared with 4.8 for patients with no missed doses (P < .01).
“We need to understand how to risk assess and how to utilize our EHR as a tool,” Dr. Neal told attendees.
Dr. Neal reported disclosures related to Janssen Pharmaceuticals, CSL Behring, Accriva Diagnostics, and Haemonetics, as well as a U.S. patent for a treatment of infectious and inflammatory disorders, and laboratory funding from the National Institutes of Health, Department of Defense, and the Biomedical Advanced Research and Development Authority.
SOURCE: Neal MD. Presentation at the American College of Surgeons Clinical Congress. 2018 Oct 25.
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